Vasopressin

Patents covering BioVie’s terlipressin liquid formulation now secured in the United States, India and Chile, and are pending in nine additional markets Formulation has demonstrated room-temperature stability for up to 24 months, representing an important advantage for treating patients with cirrhosis and ascites in the home-care setting CARSON CITY, Nev., Oct. 01, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 17/611,478 entitled "Formulations of Terlipressin." This Notice of Allowance is expected to result in the issuance of a US patent once administrative processes are completed. The allowed claims cover a novel liquid formulation of terlipressin acetate that has stability at room temperature for two years and can be packaged in a pre-filled syringe. BioVie expects the resulting patent will be approved for listing in the Orange Book. The patent supports BioVie’s liquid formulation of terlipressin for development of a more patient-centric ambulatory treatment regimen for patients with ascites and hepatic failure in the US. Patients with cirrhosis and ascites have large volumes of fluid accumulate in the abdomen (often exceeding 5 liters) due to liver and kidney dysfunction. Patients that progress to refractory ascites face a one-year survival rate of approximately 50%1. To date, there is no approved medical therapy specifically for refractory ascites. Management of these patients is based upon procedures such as large-volume paracentesis and TIPS, which only provide temporary relief, lack disease-modifying effects, and lead to frequent life-threatening complications. "Terlipressin is a drug used in over 40 countries to treat related complications of liver cirrhosis that was only recently approved in the US as a lyophilized powder for in-hospital use, which requires reconstitution with sterile sodium chloride and refrigerated storage conditions for proper administration,” said Cuong Do, BioVie’s President and CEO. “Our novel liquid formulation of terlipressin is stable at room temperature for up to 24 months, offering an important advantage for treating patients with cirrhosis and ascites, particularly in the home-care setting. The pre-filled syringe format can improve dosing convenience and safety. The receipt of this patent will significantly strengthen BIV201’s intellectual property protection and increase the value proposition behind our BIV201 program.” In addition to the US, BioVie has received patent protection for its liquid formulation of terlipressin in India and Chile, and has patents pending in Australia, Canada, China, Europe, Hong Kong, Japan, South Korea, Mexico and Brazil. About Ascites and Cirrhosis Ascites (the excessive build-up of fluid in the abdomen) is the most common complication of advanced (“decompensated”) liver cirrhosis and can be life-threatening. In advanced liver cirrhosis, the liver becomes “clogged” and blood accumulates in the region below (called the splanchnic bed). With blood pooling below the liver, the blood volume in the arteries decreases and the person with cirrhosis experiences low effective blood volume. In an effort to correct this situation, the brain sends signals via the renin-angiotensin-aldosterone system (RAAS) to the kidneys to retain extreme amounts of water and salt to attempt to reflexively increase the blood volume in the arteries. The excess liquid weeps from the lymphatic system and collects in the abdomen – which is when ascites appears. Advanced liver cirrhosis is most-commonly caused by the progression of NASH (non-alcoholic steatohepatitis), alcoholism, and infection with Hepatitis B & C. Chronic liver disease (“CLD”), including cirrhosis, and is responsible for the death of 42,000 Americans each year. As a population, people diagnosed with both liver cirrhosis and ascites experience frequent hospital readmissions each year, incurring an estimated $5 billion in annual treatment costs.2 About BIV201BIV201 (terlipressin for continuous infusion) is a prefilled syringe or vial with BioVie’s patented liquid formulation of terlipressin acetate. A synthetic analogue of vasopressin, terlipressin has been studied extensively overseas and is approved in more than 40 countries for in-hospital treatment of two deadly conditions related to ascites (bleeding esophageal varices, “BEV” and hepatorenal syndrome, “HRS”). Terlipressin has the potential to reduce the presence of ascites in the abdomen through vasoconstricting the blood vessels where the blood is pooling, hence restoring blood flow through the kidneys and liver. This reduces portal vein pressure and increases blood volume in the arteries. Consequently, the body may respond by shutting down the RAAS system which has been generating the ascites. Terlipressin, a medication employed in over 40 countries to manage complications associated with liver cirrhosis, has recently gained U.S. approval as a lyophilized powder that requires reconstitution with sodium chloride and refrigerated storage up to 48 hours for proper administration. BioVie’s unique liquid formulation of terlipressin has demonstrated stability, not only under refrigerated conditions, but also at room temperature for up to 24 months, which can be an important advantage for treating patients with cirrhosis and ascites, particularly in the home-care setting. The Company has received patent protection for its liquid formulation of terlipressin in India and Chile; a notice of allowance in the US; and patents are pending in Australia, Canada, China, Europe, Hong Kong, Japan, South Korea, Mexico and Brazil. In the US, BioVie has secured Orphan Drug designation and Fast Track status covering the use of BIV201 (continuous infusion terlipressin) for the treatment of ascites due to liver cirrhosis. BIV201 also has an Orphan drug designation for treating HRS and BioVie has reached agreement with the FDA on the design, duration, dosing and endpoints of a Phase 3 trial to evaluated BIV201 for the treatment of HRS-AKI (acute kidney injury) that could potentially be sufficient to support an NDA filing. About BioVie Inc.BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders (Long COVID, AD and PD) and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of AD and PD. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the reduction of further decompensation in participants with liver cirrhosis and ascites. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit www.bioviepharma.com. Forward-Looking StatementsThis press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. References1 Gines P, Quintero E, Arroyo V, et al. Compensated cirrhosis: natural history and prognostic factors. Hepatology 1987; 7: 122–128. 2 Mortimer R, Volk M., Mortimer S, et al. U.S. hospitalization burden of patients with cirrhosis and ascites receiving paracentesis. Presented as a poster presentation, Liver Meeting, Nov 2022, Washington DC For Investor Relations Inquiries:Bruce MackleManaging Director, LifeSci Advisors, LLCbmackle@lifesciadvisors.com For Media Relations Inquiries:Melyssa WeibleManaging Partner, Elixir Health Public Relationsmweible@elixirhealthpr.com

MALVERN, Pa., May 30, 2024 /PRNewswire/ -- Endo, Inc. ("Endo" or the "Company"), a newly formed entity that recently acquired (the "Acquisition") substantially all of the assets of Endo International plc ("EIP") as contemplated by EIP's plan of reorganization (the "Plan"), today made select first-quarter 2024 financial results for EIP available to investors. EIP's first-quarter financial results were in-line with its previously provided expectations. Endo is providing the following historical financial information of EIP because, from Endo's formation through March 31, 2024, it had no operations, business transactions or activities other than those incidental to its formation or taken in contemplation of the Plan (including the Acquisition). Endo had no other assets or liabilities during the periods presented in this release. The following historical financial information of EIP does not give effect to the transactions contemplated by the Plan or the application of fresh start accounting expected to apply to Endo's financial information beginning in the second quarter of 2024. EIP FIRST-QUARTER FINANCIAL PERFORMANCE (in thousands) EIP CONSOLIDATED FINANCIAL RESULTS Total revenues were $420 million in first-quarter 2024, a decrease of 19% compared to $515 million in first-quarter 2023. This decrease was primarily attributable to decreased revenues from the Generic Pharmaceuticals segment. Reported Net Loss in first-quarter 2024 was $154 million compared to reported Net Loss of $3 million in first-quarter 2023. This change was primarily due to increased expenses related to the Chapter 11 reorganization process and decreased revenues. Adjusted Net Income in first-quarter 2024 was $131 million compared to $193 million in first-quarter 2023. This change was primarily driven by decreased revenues. BRANDED PHARMACEUTICALS SEGMENT First-quarter 2024 Branded Pharmaceuticals segment revenues were $201 million compared to $198 million during first-quarter 2023. Specialty Products revenues increased 4% to $148 million in first-quarter 2024 compared to $142 million in first-quarter 2023. This change was primarily due to an increase in XIAFLEX® revenues, partially offset by a decrease in SUPPRELIN® LA revenues mainly driven by lower volumes. First-quarter 2024 XIAFLEX® revenues were $113 million, an increase of 17% compared to $97 million during first-quarter 2023 driven by increased net selling price and increased volumes. STERILE INJECTABLES SEGMENT First-quarter 2024 Sterile Injectables segment revenues were $98 million, a decrease of 3% compared to $101 million during first-quarter 2023. This decrease was primarily attributable to competitive pressure on a number of products and was partially offset by increased VASOSTRICT® and ADRENALIN® revenues driven by higher volumes. GENERIC PHARMACEUTICALS SEGMENT First-quarter 2024 Generic Pharmaceuticals segment revenues were $103 million, a decrease of 48% compared to $198 million during first-quarter 2023. This decrease was primarily attributable to competitive pressure on varenicline tablets, the generic version of Chantix®, and dexlansoprazole delayed release capsules, the generic version of Dexilant®, partially offset by increased revenues from lidocaine patch 5%, the generic version of LIDODERM®. INTERNATIONAL PHARMACEUTICALS SEGMENT First-quarter 2024 International Pharmaceuticals segment revenues were $17 million compared to $18 million during first-quarter 2023. CASH, CASH FLOW AND OTHER UPDATES As of March 31, 2024, EIP had approximately $641 million in unrestricted cash and cash equivalents. First-quarter 2024 net cash provided by operating activities was approximately $26 million compared to approximately $62 million net cash provided by operating activities during first-quarter 2023. This change was primarily driven by decreased revenues. 2024 FINANCIAL EXPECTATIONS Endo is providing financial guidance for the full-year ending December 31, 2024, which guidance includes EIP's financial results prior to the Acquisition. All expectations provided by Endo, which are unchanged from expectations previously provided by EIP, are forward-looking and actual results may differ materially and adversely from such expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements." CONFERENCE CALL INFORMATION Endo will host a conference call to discuss this press release tomorrow, May 31, 2024, at 8:30 a.m. ET for registered holders of its debt and equity securities. There are three ways to join the call: Phone link to register and receive an automatic callback when conference call begins: Phone dial-in number with operator support: 800-836-8184 (U.S. and Canada toll-free) or 646-357-8785 Webcast: Please dial in 10 minutes prior to the scheduled start time. Dexilant® is a registered trademark of Takeda Pharmaceutical U.S.A., Inc. Chantix® is a registered trademark of Pfizer Inc. LIDODERM® is a registered trademark of Endo, Inc. FINANCIAL SCHEDULES The following table presents Endo International plc's unaudited Total revenues, net for the three months ended March 31, 2024 and 2023 (dollars in thousands): The following table presents unaudited Condensed Consolidated Statement of Operations data of Endo International plc for the three months ended March 31, 2024 and 2023 (in thousands): The following table presents unaudited Condensed Consolidated Balance Sheet data of Endo International plc at March 31, 2024 and December 31, 2023 (in thousands): The following table presents unaudited Condensed Consolidated Statement of Cash Flow data of Endo International plc for the three months ended March 31, 2024 and 2023 (in thousands): SUPPLEMENTAL FINANCIAL INFORMATION Non-GAAP Financial Measures To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain financial information of Endo International in this release that are not prescribed by or prepared in accordance with GAAP. The Company utilizes these non-GAAP financial measures as supplements to financial measures determined in accordance with GAAP when evaluating operating performance and the Company believes that these measures will be used by certain investors to evaluate operating results. The Company believes that presenting these non-GAAP financial measures provides useful information about performance across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable, as more fully described in the reconciliation tables below. Despite the importance of these measures to management in goal setting and performance measurement, the Company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income (unlike GAAP net income and its components) may differ from, and may not be comparable to, the calculation of similar measures of other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance. These non-GAAP financial measures should not be viewed in isolation or as substitutes for, or superior to, financial measures calculated in accordance with GAAP. Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant. The tables below provide reconciliations of certain of the non-GAAP financial measures included in this release to their most directly comparable GAAP metrics. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section. Reconciliation of Net Loss (GAAP) to EBITDA (non-GAAP) and Adjusted EBITDA (non-GAAP) The following table provides a reconciliation of Net loss (GAAP) to Adjusted EBITDA (non-GAAP) for the three months ended March 31, 2024 and 2023 (in thousands): Reconciliation of Net Loss (GAAP) to Adjusted Net Income (non-GAAP) The following table provides a reconciliation of the Endo International plc's Net Loss (GAAP) to Adjusted Net Income (non-GAAP) for the three months ended March 31, 2024 and 2023 (in thousands): Reconciliation of Select Other Adjusted Income Statement Data (non-GAAP) The following tables provide detailed reconciliations of select other income statement data for Endo International between the GAAP and non-GAAP amounts for the three months ended March 31, 2024 and 2023 (in thousands, except per share data): Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures SEC Review Endo has confidentially submitted a draft registration statement with the U.S. Securities and Exchange Commission (the "SEC") to effectuate its previously announced goal of listing its common stock on a national stock exchange. The registration statement includes a description of Endo's business, financial and other information, some of which is included in this press release. Comments by the SEC on the registration statement may require modification or reformulation of the description of Endo's business. As a result, financial information that Endo presents in the future may differ in presentation or calculation from the information presented herein. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended. About Endo Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This release includes certain statements, claims, estimates, predictions and other information prepared and provided by Endo with respect to the anticipated future performance of Endo and its subsidiaries. Such statements include or are based on "forward looking statements" including, but not limited to, statements relating to financial expectations or guidance and any other statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: the effects of the emergence of EIP's operating assets from the Chapter 11 financial restructuring process, including as it relates to the accounting for the effects of the Plan and the application of fresh start accounting; changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the ability to develop and expand our product pipeline and to continue to develop the market for XIAFLEX® and other branded or unbranded products; the effectiveness of advertising and other promotional campaigns; and the timely and successful implementation of any strategic priorities. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Copies of the Company's press releases and additional information about the Company are available at or you can contact the Company's Investor Relations Department at [email protected]. SOURCE Endo, Inc. SOURCE Endo, Inc.